Jan/Feb/Mar 2023

Volume 24, Issue 1

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Articles in this Issue

Control and Selection of API Solid State Attributes

A stable, reproducible solid form is the basis of the majority of pharmaceutical dosage forms, including tablets, capsules and inhaled products. Selecting the optimal solid form has become increasingly important in the development... read more
The Role of Quality Agreements in the Relationships between Pharmaceutical Companies and their...

Pharmaceutical and Medical Device companies often use Contract Manufacturing Organizations (CMOs) for new product development, to procure services that they may not have expertise or facilities internally, manage their limited ... read more
2023 Cold Chain Predictions

Each year for the past two years, the underlying theme of nearly every year-in-review or predictions for the following year was normalcy. The world craved fewer day-to-day disruptions, and in some respects, the return of familiar ... read more
The Promise and Pressures of Biologics R&D

Biologic drugs have increasingly delivered treatments for cancer and rare diseases and continue to prove effective in other wide-ranging areas, from neurological and metabolic disorders to respiratory and cardiovascular diseases. ... read more
The FDA Moves to Modernize Standards on Over-the-Counter Drugs

As 2023 begins in earnest, the healthcare industry is evolving to meet more contemporary needs, including for patients who prefer the option of self-treatment. Those who choose to self-treat can self-diagnose their illness and ... read more
Researchers Scramble to Meet Clinical Trial Diversity Rules

Clinical trials are the long and complex process by which biopharmaceutical companies must prove the safety and efficacy of investigational new therapies to FDA before they can be considered for marketing approvals. The process ... read more
How Decentralized Storage Can Make the Pharmaceutical Industry More Secure

Pharmaceutical companies manage various forms of highly sensitive data, such as personal information about consumers, patent information, and the results of new research and clinical trials. Unfortunately, this huge volume of data... read more
Facility Tour: Advancing Inhaled and Injectable Product Development

The path to bring a pharmaceutical product to market, from initial research to development to commercial-scale manufacturing, is a long and resource-intensive process. Companies that provide product development services are ... read more
Putting the B2C in Clinical Trials: How Consumerization Impacts Patient Expectations — and...

An estimated 50% of clinical trials will be hybrid or fully virtual decentralized by 2024.1 This leaves the pharmaceutical industry faced with unique supply chain challenges in meeting patient expectations. One of those challenges... read more
Regulatory Operations – Enhanced Business Processes Will Fuel a Data-Driven Future

There is general agreement now that the shift away from inconsistent manual, document oriented processes towards agreed use of standards-based data will be pivotal to transforming key processes. Remco Munnik noted that, up to ... read more
An Interview with Dr. Uwe Hanenberg - Head of Product Development, Oral Solid Dose

The company has the expertise and capability to work with formulations for new chemical entities (NCEs), improve products with existing drug substances, development of generics, and support all phases of clinical development. ... read more
Digital Knowledge Management Drives the Connected Pharma Enterprise

The rapid development, manufacture and distribution of vaccines that began in early 2020 to combat COVID-19 showed that perseverance and sheer human will can overcome legacy challenges to meet a global emergency, quickly and ... read more
A Quarterly Review of New Drug Applications – October-December 2022

This quarterly review of new drug applications contains data for applications approved for the first time during the fourth quarter of 2022, which includes New Molecular Entities (NMEs) and new biologics. A total of 29 ... read more
Editor's Message: What's Real?

I fired up the chat function on their website and once I got past the initial chatbot, I was transferred to a real customer service rep – or so I thought. This chat sounded suspiciously like the first one. Then when this rep(?) ... read more